Projects/Programs

Displaying 1 - 25 of 32

AAPS Interlaboratory Study: Protein Aggregation and Immunogenicity

Ongoing

To ensure the safety and efficacy of protein-based biotherapeutics, manufacturers strive to avoid unwanted immune responses caused by the biotherapeutic. Protein immunogenicity is a complex topic and depends on multiple factors related to the product, patient profile, and treatment. 1 , 2

Biomanufacturing Initiative

Ongoing

The objective of the NIST biomanufacturing program is to support US biopharmaceutical industry delivery of high quality and low cost protein drugs around the world. The mission is fulfilled through the development of standards, measurement science, and state of the art tools that support advances in

Cell Counting for Cell Therapies

Ongoing

Recent Publications and Resources for Cell Counting and Related Measurements Tools NOW AVAILABLE : COMET (Counting Method Evaluation Tool) , A Shiny Application that executes the statistical analysis and reporting outlined in ISO 20391-2:2019 https://cell-counting.shinyapps.io/COMET/ Standards ISO

Cell Line Authentication

Ongoing

Cell Line Authentication – The scientific community has responded to the misidentification of human cell lines with validated methods to authenticate these cells; however, there are few assays available for nonhuman cell line identification. We have developed multiplex polymerase chain reaction (PCR

Combating Antibiotic Resistance

Ongoing

We are developing in vitro systems to generate controlled chemical and community environments that mimic the features of real-world that are important determinants for evolutionary rate and resistance potential. In addition, we are developing tools to isolate and analyze single bacteria along the

Consistency Analysis and Uncertainty in ‘omic Data

Ongoing

‘Omics is increasingly moving out of the laboratory and towards use in industrial and commercial applications. For instance, in biomanufacturing, there is a need for quality control when developing biotherapeutics, which will almost certainly require a machine-learning classifier to separate

Data Infrastructure for Biomanufacturing Process Control

Ongoing

Objective The objective of this project is to develop measurement science that includes ontology models, ontology expression (axiomatic) patterns, guidelines for qualifying those ontologies, and distributed ontology development software that will allow U.S. manufacturers to have better access to

Development of a Collagen Fibril Reference Material for Reproducible Cell Response

Ongoing

Research is ongoing to assess what information is required to validate films of collagen as reference extracellular matrix. During the first portion of this work we will develop protocols for characterizing the prototype collagen reference material with various instrumental techniques to develop

ERCC 2.0: Developing a New Suite of RNA Controls

Completed

Requested RNA Control products include: Transcript isoforms; New and improved messenger RNA mimics and mixture formulations; microRNA and other small RNA molecules; and Cancer fusion transcripts. ERCC technical working groups are developing design specifications, RNA control products, and analysis

Fluid Suspensions and Emulsions

Ongoing

We aim to: Develop measurement capabilities to relate solution structure and viscosity through novel combinations of unique small volume, high shear rate rheometers with scattering and particle-imaging techniques. A major application of these capabilities is understanding self-association in fluids

Glycan Standard Reference Materials

Ongoing

Now Available A glycan-based NIST Standard Reference Material ( SRM 3655 Glycans in Solution) supports the biomanufacturing and protein therapeutics communities with a set of 13 individually-bottled, pure glycoforms including those most commonly observed as N-linked glycans on therapeutic monoclonal

HDX-MS for Biopharmaceutical Analysis

Ongoing

I ntended Impact This project is designed to improve, test, and validate hydrogen/deuterium exchange mass spectrometry (HDX-MS) metrology for the determination of dynamical properties of therapeutic proteins and glycoproteins. Objectives Explore structure-function relationships between glycan

Improved Benchtop Connectivity to Complex Microfluidic Devices

Completed

Intended impact Microfluidic devices with many fluidic and pneumatic inlets are difficult to connect to benchtop reservoirs and controllers. Many hours can be spent sorting, untangling, and connecting tubing to a single device. If one then finds that the device is not fully functional, the process

Live Cell Imaging of Induced Pluripotent Stem Cell Populations

Ongoing

As part of our program in Cell Biology , our live cell image program supports the advancement of induced pluripotent stem cell (iPSC) technology in three ways: 1) Identification of process control measurements: A critical component to the translation of iPSCs into therapeutic applications is to

Monoclonal Antibody Mass Spectral Libraries

Ongoing

Intended Impact Modern mass spectrometers used in the field of proteomics and glycomics are capable of profiling hundreds, and even thousands of molecules in a single experiment. Each of these compounds is isolated and fragmented to form a mass spectrum. Therefore, interpretation of these mass

Nanoparticle Metrology in Complex Cellular Environments

Completed

Nanoparticle interactions with individual cells. Existing techniques to evaluate nanoparticle incorporation include ICP-AES or ICP-MS, which atomize entire samples (thousands of cells) and detect nanoparticles by quantifying the elemental composition. Bulk techniques provide general trends averaged

NIST Monoclonal Antibody Reference Material 8671

Ongoing

The NISTmAb material is a recombinant humanized IgG1κ expressed in murine suspension culture. It is an »150 kDa homodimer of two identical light chains and two identical heavy chains linked through both inter- and intra-chain disulfide bonds. The protein has low abundance post-translational

NIST PS1 Primary Standard for quantitative NMR (Benzoic Acid)

Completed

With explicit SI linkage, the overall impact of this apical reference material is profound—this primary standard, as well as forthcoming members of its class, provides technology transfer of chemical purity realization to the commercial sector for characterization of many thousands of organic

NIST23: Updates to the NIST Tandem and Electron Ionization Spectral Libraries

Ongoing

NIST Tandem Mass Spectral Library, 2023 release 51,501compounds 60% increase over the 2020 release 399,267 precursor Ions 2.4 million spectra Fragmentation methods 49,590 HRAM (high res accurate mass) compounds 51,292 QTOF, HCD, IT-HRAM, QqQ compounds 49,561 ion trap compounds (low res., up to MS 4)

Orthogonal Measurements

Ongoing

Definitions: Orthogonal measurements: Measurements that use different physical principles to measure the same property of the same sample with the goal of minimizing method-specific biases and interferences. Complementary measurements: Measurements that corroborate each other to support the same

Point-of-Care Pharmaceutical Manufacturing & Precision Medicine

Ongoing

We are employing quality by design (QbD) and risk assessment (cause-and-effect) approaches to investigate production technologies ( e.g., drop on demand or inkjet printing platforms) and appropriate analytical control strategies for point-of-care manufacture of narrow therapeutic index drugs

Protein Preservation

Completed

This project is an integral part of a cooperative effort – led by NIST, and partially funded by NIH/ NIBIB – which includes the University of Wisconsin, the University of Colorado, and the University of Connecticut. We use the following approach to develop measurement solutions for biopharmaceutical

Protein rheology measurements

Ongoing

Intended Impact Why does the health-care industry care about rheology and scattering of protein solutions? Operations. Viscosity is a critical and fundamental constitutive input for drug delivery, device design and manufacturing. For example, high viscosity leads to poor syringeability due to

Reliable Vaccine Storage

Completed

Our group examines best practices for the storage and monitoring of vaccines in partnership with the Centers for Disease Control and Prevention’s (CDC) Vaccine Supply and Assurance Branch. Vaccines are highly temperature sensitive, and inappropriate storage conditions can render them ineffective

RMAT Laboratory Programs

Ongoing

Examples of Current Activities: Cell Counting and viability are key measurements critical for decision making from R&D to manufacturing. We recently developed an approach for evaluating the quality of cell counting measurements through experimental design and statistical analysis that does not

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